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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00111267
Other study ID # P03.0277L
Secondary ID ZonMW 2100.0067
Status Completed
Phase N/A
First received May 18, 2005
Last updated June 23, 2005
Start date May 2003
Est. completion date January 2005

Study information

Verified date May 2005
Source Wageningen University
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Interventional

Clinical Trial Summary

The purpose of this trial is to study the effects of oral vitamin B12 supplementation and vitamin B12 combined with folic acid supplementation on cognitive performance for 24 weeks in elderly people with mild vitamin B12 deficiency.


Description:

Mild vitamin B12 deficiency is highly prevalent in old age. Reasons for this high prevalence are not fully understood, but include atrophic gastritis and bacterial overgrowth which affect the absorption (active) of food-bound vitamin B12. In contrast, the ability to absorb crystalline vitamin B12 (e.g. the form found in fortified foods or vitamin pills) remains intact in old age. In both healthy and cognitively impaired elderly people, associations between vitamin B12 status and cognitive performance have been observed, and the follow-up of geriatric patients suggests effects of parenteral treatment in early cognitive impairment.

We investigated whether daily oral supplementation with 1,000 μg vitamin B12 or 1,000 μg vitamin B12 combined with 400 μg folate for 24 weeks improves cognitive performance in people over 70 years with vitamin B12 deficiency.


Recruitment information / eligibility

Status Completed
Enrollment 165
Est. completion date January 2005
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 70 Years and older
Eligibility Inclusion Criteria:

- Mild vitamin B12 deficiency:

- Low plasma vitamin B12 concentration (100 < B12 < 300 pmol/L)

- Elevated methylmalonic acid (MMA) concentration (> 0.32 umol/L)

- Creatinine concentration < 120 umol/L

Exclusion Criteria:

- Severe cognitive impairment

- Anemia

- Gastrointestinal surgery or diseases

- Use of vitamin B12 injections or supplements containing > 25 ug vitamin B12 and/or 200 ug folic acid

- < 90% compliance during a 2 week placebo run in period

- No written informed consent

- Participation in other research studies

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention


Intervention

Behavioral:
vitamin B12 supplementation

vitamin B12 + folic acid combined supplementation


Locations

Country Name City State
Netherlands Wageningen University Wageningen Gelderland

Sponsors (2)

Lead Sponsor Collaborator
Wageningen University ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cognitive performance in the domains of attention, concentration, memory, executive function, speed
Secondary Blood biochemistry including vitamin B12, methylmalonic acid, holotranscobalamin, homocysteine, and red blood cell folate
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